Barrier, Synthetic, Intraoral
Dental · 21 CFR 872.3930
A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.
Recent MDR events
83 adverse event reports on file
- INION GTR BIODEGRADABLE SYSTEMDec 15, 2022InjuryInion Oy3003407235-2022-00004
- INION GTR BIODEGRADABLE SYSTEMDec 8, 2022InjuryInion Oy3003407235-2022-00003
- INION GTR BIODEGRADABLE MEMBRANE SYSTEMDec 8, 2022InjuryInion Oy3003407235-2022-00002
- SALVIN CYTOSURGJul 21, 2021Injury1066741-2021-00001
- SALVIN CYTOSURGJul 21, 2021Injury1066741-2021-00002
- INION GTR BIODEGRADABLE MEMBRANE SYSTEMSep 24, 2020Injury3003407235-2020-00003
- MEDPOR CONTAIN SHEET 25MM X 30Jun 21, 2017InjuryStryker Orthobiologics-malvern0008010177-2017-00126
- GUIDOR BIORESORBABLE MATRIX BARRIERNov 25, 2014InjurySunstar Americas, Inc.1411485-2014-00001
- MEDPOR CONTAIN SHEET 25MM X 30Apr 17, 2013InjuryStryker Cmf-georgia0008010177-2013-00066
- MEDPOR CONTAIN SHEET 25MM X 30Apr 17, 2013InjuryStryker Cmf-georgia0008010177-2013-00068
Event type breakdown
Registered firms
29 firms currently registered for this product code
Wesley Coe (cambridge) Ltd
ELY, CAMBS Cambridgeshire, GB
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Collagen Matrix, Inc
Allendale, NJ, US
Purgo Biologics Inc.
Seongnam-si Gyeonggi, KR
Sterigenics U.s., Llc
Atlanta, GA, US
Cowellmedi Co., Ltd.
BUSAN, KR
Stryker Leibinger Gmbh & Co. Kg
FREIBURG Baden-Wurttemberg, DE
Nobel Biocare Distribution Center Bv
Venlo Limburg, NL
Sweden & Martina Inc
Naperville, IL, US
Steritec Services, Llc
ATHENS, TX, US
Life Science Outsourcing
SOMERSWORTH, NH, US
Osteogenics Biomedical, Inc.
LUBBOCK, TX, US
Salvin Dental Specialties, Llc
CHARLOTTE, NC, US
Synergy Health Sterilisation Uk Ltd
Berkshire Reading, GB
Institut Straumann Ag
BASEL Basel-Stadt, CH
Neoss Ab
Goteborg Vastra Gotaland, SE
Tbs Dental Llc
Dallas, TX, US
Unicare Biomedical, Inc.
Laguna Hills, CA, US
Collagen Matrix, Inc.
Oakland, NJ, US
Hansamed Limited Dba Citagenix
Mississauga Ontario, CA
510(k) clearances
31 clearances for this product code
- Criteria Industria E Comercio DE Produtos MedicinaisDec 8, 2023
K221851 · Lumina-PTFE Titanium
- Purgo Biologics, Inc.May 11, 2023
K222549 · OpenTex
- Cowellmedi Co., Ltd.Feb 24, 2023
K211554 · InnoGenic Non-resorbable Membrane
- B&Medi Co., Ltd.Aug 18, 2022
K210797 · Bio-MEM Ti Reinforced Membrane
- Osteogenics Biomedical, Inc.Jan 23, 2021
K201187 · Cytoplast Titanium-Reinforced PTFE Membranes
- Osteogenics Biomedical, Inc.Oct 19, 2017
K171774 · RPM Reinforced PTFE Mesh
- Salvin Dental SpecialtiesSep 8, 2016
K160493 · Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm
- Unicare Biomedical, Inc.Nov 19, 2015
K151344 · Cytoflex Tefguard Ti-Enforced Membrane